Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000682549
Ethics application status
Approved
Date submitted
7/05/2024
Date registered
29/05/2024
Date last updated
29/09/2024
Date data sharing statement initially provided
29/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Music Attuned Technology for Care via eHealth - MATCH: Study 4
Scientific title
Music Attuned Technology for Care via eHealth - MATCH: Feasibility Study with Caregivers and People Living with Dementia in the Community Setting (Study 4)
Secondary ID [1] 312088 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MATCH - Study 4
Linked study record
Trial Id: ACTRN12618001799246 - HOMESIDE RCT - tested the effectiveness of training family caregivers to use music with people living with dementia at home.
Trial Id: ACTRN12622000193774 - MATCH: Proof-of-Concept (Study 2) - tested the MATCH app in the community setting - training family caregiver via app.
Trial Id: ACTRN12623000350628: MATCH: Determining Digital Markers of Agitation (Study 3 - Stage 2) - part of the app development, run in the Residential Aged Care

Health condition
Health condition(s) or problem(s) studied:
behavioural symptoms of dementia 333712 0
psychological symptoms of dementia 333713 0
caregivers' stress 333714 0
Condition category
Condition code
Neurological 330395 330395 0 0
Dementias
Neurological 330396 330396 0 0
Alzheimer's disease
Neurological 330397 330397 0 0
Other neurological disorders
Alternative and Complementary Medicine 330398 330398 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dyads of a person living with dementia (PwD) and their caregiver (CG) will be asked to use the Music Attuned Technology for Care via eHealth for HomeCare setting (MATCH-HC) mobile application and/or the music strategies learned from the MATCH training within the application for 12 weeks. MATCH-HC includes training videos for the CGs to learn music strategies (the use of music for relaxation, mood regulation, engaging and connecting, support personal care, and movement and exercise) they can use with the person they care for. Within the mobile application, the PwD and their CG are also invited to create various music playlists that they can use for different purposes. There is no time limit on the use of MATCH app or strategies each day. The dyads can use them 'as they need it'.

Before starting to use the MATCH strategies, the caregivers will be asked to complete the MATCH training delivered via a mobile application. The training is offered through instructional and demonstration videos, guides and a sample music playlist. The videos introduce the caregivers to the methods and strategies for using music to assist the PwD in their daily routines. The learning modules comprise: a) Introduction, b) Relaxation, c) Mood Regulation, d) Engaging and Connecting, e) Support Personal Care, and f) Movement and Exercise. Each training video lasts for 2-7 minutes. All modules are anticipated to take a total of less than 2 hours. Upon completing each module, CGs can immediately start using MATCH. They can start developing their own music-listening playlist based on the PwD's music preference and try out the strategies taught in the Learning Modules.

If the person with dementia transitions to residential aged care during the trial period, the dyad will be asked if they would like to continue the study ("transition study").. Upon their agreement and consent, they will continue to use MATCH for another six weeks, beginning from the point they gave their consent.

Throughout the study, the researchers will maintain the web-portal analytics to monitor the use of MATCH-HC app. When there is a period of absence, a notification will appear on the app to remind the participant to use MATCH-HC and identify challenges they are experiencing.
Intervention code [1] 328525 0
Treatment: Devices
Intervention code [2] 328526 0
Behaviour
Comparator / control treatment
No comparator will be used at this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338154 0
Adherence
Timepoint [1] 338154 0
Intervention will be run as PRN (as the thing is needed) after the training is completed.
Secondary outcome [1] 434736 0
Acceptability
Timepoint [1] 434736 0
84 days post-trial commencement
Secondary outcome [2] 434737 0
Usability (how easily the MATCH-HC mobile application can achieve its goals and how efficiently users can interact with the system through its interface)
Timepoint [2] 434737 0
84 days post-trial commencement
Secondary outcome [3] 434739 0
Preliminary effectiveness
Timepoint [3] 434739 0
Pre-trial commencement, 42 days post-trial commencement and 84 days post-trial commencement
For transition study: Pre-trial commencement, 42 days post-trial commencement
Secondary outcome [4] 434740 0
Preliminary effectiveness
Timepoint [4] 434740 0
PRN (All participants will be asked to complete an impact assessment after using the app. If they use the app, their usage will be automatically recorded in the database. However, if one day they do not use the app, a pop-up notification will appear on the app the day after (next morning) to identify their reason for not using the app)
Secondary outcome [5] 434741 0
Quality of life (QoL) for caregivers
Timepoint [5] 434741 0
Pre-trial commencement, 42 days post-trial commencement and 84 days post-trial commencement
Secondary outcome [6] 434742 0
Care costs
Timepoint [6] 434742 0
Pre-trial commencement and 84 days post-trial commencement
Secondary outcome [7] 434743 0
Caregiver burden
Timepoint [7] 434743 0
Pre-trial commencement, 42 days post-trial commencement and 84 days post-trial commencement
Secondary outcome [8] 434744 0
Training evaluation (knowledge gained)
Timepoint [8] 434744 0
Pre-trial commencement and 84 days post-trial commencement
Secondary outcome [9] 435161 0
Quality of Life for PwD
Timepoint [9] 435161 0
Pre-trial commencement, 42 days post-trial commencement and 84 days post-trial commencement

Eligibility
Key inclusion criteria
For HomeCare stage:
Inclusion criteria of people living with dementia:
a) Living at home, co-habiting with at least one other person who is nominated to be the primary caregiver
b) Formal diagnosis of dementia
c) NPI-Q Severity score of 6 or higher

Inclusion criteria of caregivers:
d) Close in relationship to the person living with dementia
e) Co-habiting with the person with dementia

For Transition stage:
Inclusion criteria of people living with dementia:
- Participants enrolled at the HomeCare stage who communicates the decision to transition into residential aged care (RAC) during the study period
- Dyads eligible for the HomeCare stage (meet criteria [b] and [c], however, transitioning into RAC at the enrolment (do not meet criteria [a])

Inclusion criteria of caregivers:
- close in relationship to the person living with dementia
- co-habiting with the person with dementia, before the transition into RAC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Dyads who do not have access to the internet or a mobile device as the app needs to be
downloaded and accessed for study participation.
• Hearing impairment that is not overcome by hearing support such as hearing aids for both
CG and PwD.
• The CG does not have good knowledge of English. This is because the mobile app version is
only in English. Versions in other languages will be available as advanced features in the
mobile app are integrated. We do not anticipate this occurring during the period of this
feasibility study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The primary study will include a total sample of 65 dyads. In addition, a sub-cohort of participants (10-15% enrolled in the primary study) who transition to RAC during the study will be included in the "transition study".
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For sample size:
A precision-based sample size calculation was undertaken to determine the sample size required to observe a proportion of 80% adhering to MATCH (primary outcome) within +/- 10%. A total sample size of 65 dyads is required for the HomeCare stage based on the precision of the two-sided 95% confidence interval (CI) of the true underlying proportion of participants who adhere is at most +/- 10% when assuming a proportion of 80% ( i.e. CI [70% to 90%]) using the Wald method to obtain the 95% confidence interval. To account for approximately 20% attrition, we will recruit 82 dyads.

For the Transition stage, we estimate a sub-group (10 to 15%) of the PwD enrolled will transition into RAC during the study. Assuming 20% attrition, we expect to enrol 10 dyads for an exploratory sub-study.

For analysis:
A detailed statistical analysis plan will be developed by the study biostatistician(s). In brief, to
address the primary aim (Aim 4.1 in the protocol), the percentage of dyads who adhere to MATCH in the HomeCare setting will be calculated, with corresponding 95% Wald confidence intervals calculated. Adherence is defined as using MATCH on at least 80% of occasions on which the CG identified that it was needed. The study aims to have at least 80% of dyads adhering to the intervention. We will not calculate adherence during the transition to residential aged care as this will not be feasible as family are not always present/on site to implement as needed (PRN)

Descriptive statistics (e.g., mean and standard deviation or median and interquartile range, as
appropriate) will be used to summarise post-study usability and acceptability scores in the
HomeCare setting (Aim 4.2 in the protocol). BPSD and quality of life of the PwD and/or CG (Aim 4.3 in the protocol) and caregiver burden (Aim 4.4 in the protocol) will be summarised descriptively pre-, mid- and post-intervention using means and standard deviations or medians and interquartile ranges, as appropriate for both the HomeCare and Transition dyads. Linear mixed models with a random intercept for dyad will be used to examine change over time in each of these outcomes in the HomeCare setting, with and without adjustment for key potential confounders (e.g., age of PwD), noting that the number of adjustment variables will be limited by the small sample size, to allow estimation of the change in mean (with corresponding 95% confidence interval) from pre- to post-trial. This analysis is not possible in the Transition setting due to small sample sizes.

A within-trial economic analysis, with a societal perspective will be performed using individual PwD and CG level data. The analytical approaches will take the cost-effectiveness analyses. The incremental cost-effectiveness ratio (ICER), planes and cost-effectiveness acceptability curves will be based on trial evidence. The effect measures for the cost-effectiveness analysis will be quality-adjusted life years (QALY) and NPI-Q. We will measure the time spent in informal care, productivity loss will include CG's stopping or reducing hours of work to care for the PwD and medication costs.

Descriptive statistics (e.g., mean and standard deviation or median and interquartile range, as
appropriate) will be used to summarise pre- and post-intervention training scores (Aim 4.5) from the 25-item quiz in both the HomeCare and Transition setting. Changes from pre-post scores will be estimated (including 95% confidence intervals) using linear regression models, with adjustment for key potential confounders (e.g., age of CG) for the HomeCare setting only. This analysis is not possible in the Transition setting due to small sample sizes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
30/07/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
164
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316444 0
Government body
Name [1] 316444 0
Medical Research Future Fund (National Health and Medical Research Council)
Country [1] 316444 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318614 0
None
Name [1] 318614 0
Address [1] 318614 0
Country [1] 318614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315236 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 315236 0
Ethics committee country [1] 315236 0
Australia
Date submitted for ethics approval [1] 315236 0
28/03/2024
Approval date [1] 315236 0
03/05/2024
Ethics approval number [1] 315236 0
2024-29201-52999-3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134086 0
Prof Felicity Baker
Address 134086 0
Building 141, Office 106, Gate 12, Royal Parade. The University of Melbourne - Parkville Campus. VIC 3052.
Country 134086 0
Australia
Phone 134086 0
+61 402172795
Fax 134086 0
Email 134086 0
[email protected]
Contact person for public queries
Name 134087 0
Dr Tanara Vieira Sousa
Address 134087 0
Building 141, Gate 12, Royal Parade. The University of Melbourne - Parkville Campus. VIC 3052.
Country 134087 0
Australia
Phone 134087 0
+61 403159473
Fax 134087 0
Email 134087 0
[email protected]
Contact person for scientific queries
Name 134088 0
Felicity Baker
Address 134088 0
Building 141, Office 106, Gate 12, Royal Parade. The University of Melbourne - Parkville Campus. VIC 3052.
Country 134088 0
Australia
Phone 134088 0
+61 402172795
Fax 134088 0
Email 134088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identified data from assessments and demographics will be made available after the end of the MATCH Project, including manuscripts published in a Public Data Repository.
When will data be available (start and end dates)?
01/01/2027 - unlimited timeline
Available to whom?
To the general public
Available for what types of analyses?
No restrictions
How or where can data be obtained?
Assessing the Public public Data Repository or via email to the PI Professor Felicity Baker: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22348Clinical study report  [email protected] By request to the Principal Investigator or via th... [More Details]
22349Ethical approval  [email protected]



Results publications and other study-related documents

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